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CTRI Number  CTRI/2026/02/104352 [Registered on: 19/02/2026] Trial Registered Prospectively
Last Modified On: 18/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two laryngoscopes in pregnant patients with high blood pressure undergoing caesarean section under general anaesthesia 
Scientific Title of Study   COMPARISON OF INTUBATING CONDITIONS WITH KINGVISION VIDEOLARYNGOSCOPE AND CONVENTIONAL LARYNGOSCOPE IN PATIENTS WITH PRE-ECLAMPSIA REQUIRING GENERAL ANAESTHESIA FOR CAESAREAN SECTION 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rashmi Salhotra 
Designation  Professor 
Affiliation  University College Of Medical Sciences 
Address  UCMS and GTBH
second floor hospital block near main icu
East
DELHI
110095
India 
Phone  9625900739  
Fax    
Email  rashmichabra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rashmi Salhotra 
Designation  Professor 
Affiliation  University College Of Medical Sciences 
Address  UCMS and GTBH
second floor hospital block near main icu
East
DELHI
110095
India 
Phone  9625900739  
Fax    
Email  Rashmichabra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Rashmi Salhotra 
Designation  Professor 
Affiliation  University College Of Medical Sciences 
Address  UCMS and GTBH
second floor, hospital block near main icu
East
DELHI
110095
India 
Phone  9625900739  
Fax    
Email  Rashmichabra@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  University College of Medical Sciences 
Address  UCMS/GTBH Dilshad Garden Shahdara- Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rashmi Salhotra  UCMS/GTBH  Deaprtment of Anaesthesia and Critical Care. Second Floor. Near main icu
East
DELHI 
9625900739

Rashmichabra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Guru Teg Bahadur Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  King Vision Video Laryngoscope  A channeled KVL will be used for intubation. A tracheal tube with an internal diameter of 7.0 mm will be mounted on the KVL. 
Comparator Agent  Macintosh Laryngoscope  Macintosh Laryngoscope will be used for intubation. A tracheal tube with an internal diameter of 7.0 mm will be used 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Twenty two consenting pregnant patients in each group with pre-eclampsia as diagnosed by ACOG guidelines of age more than 18 years and ASA physical status 2 and 3 scheduled for caesarean section requiring GA with tracheal intubation will be enrolled. 
 
ExclusionCriteria 
Details  Patient refusal patients requiring awake intubation and eclampsia 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients having Cormack and Lehane glottic view grade one  Proportion of patients having Cormack and Lehane glottic view grade one at time of laryngoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
Laryngoscopy time
Tube insertion time
Time to successful intubation
Intubation difficulty Score (IDS)
First attempt success rate
Percentage of difficult intubation
 
All parameters at the time points of laryngoscopy & intubation 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  


Rationale Videolaryngoscopes are being widely used as first choice for tracheal intubation. Anatomic and physiologic changes during pregnancy place the parturient at increased risk for airway management problems. Obstetric patients with pre-eclampsia have already anticipated difficult airway. The predictors of difficult direct laryngoscopy are not applicable to predict a difficult videolaryngoscopy.

 

Title To compare intubating conditions with Kingvision videolaryngoscope and conventional laryngoscope in pre-eclampsia patients requiring general anaesthesia for caesarean section.

 

Objectives To evaluate and compare the difficulty encountered by anaesthesiologists by Kingvision videolaryngoscopy vs conventional laryngoscopy in terms of Cormack Lehane grade laryngoscopy time tube insertion time time for successful intubation intubation difficulty score percentage of difficult intubation and success rate of intubation in the first attempt.

 

Methods This prospective, randomised study will be conducted in the Department of Anaesthesiology and Critical Care, UCMS and GTBH from March 2026 to December 2026. Pre-eclampsia patients of age more than18 years and ASA physical status 2 3 with Mallampati score 2 3 scheduled for caesarean section requiring General Anaesthesia  with Tracheal Intubation will be enrolled. Patients requiring awake intubation and refusing to participate will be excluded. Patients will be randomly allocated to one of the two groups. Standard anaesthesia technique will be followed and intubation will be performed using a Kingvision videolaryngoscope  or conventional Macintosh laryngoscope depending on the group allocated.

 

Sample size and Statistical analysis According to a previous study it has been reported that 79.6 per cent patient in whom intubation was done using Kingvision videolaryngoscope  had CL grade 1 views and 33.8 per cent patient had CL grade 1 views in Macintosh laryngoscope group in obstetric patients. To estimate the same difference using two-tailed test at alpha equal to 5 per cent and power 80 per cent minimum  sample size of  22 in each group is required.


 

 

 
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